KR20160057481A - Systems and methods for diagnostic testing - Google Patents

Abstract

A device, system and method for performing diagnostic tests are disclosed. The diagnostic system can perform analytical tests and communicate with a portable multifunction device (PMD) or other computing device. The system includes an analyzer configured to transmit an electrical signal between the computing device and the sample cartridge. Through communication with the sample cartridge through the analyzer, various tests can be performed and controlled by the computing device. These analytical tests include, but are not limited to, the detection or quantification of chemicals from a sample input, whether gas, liquid or otherwise, the detection or quantification of analytes, antibodies or antigens, the detection of genetic or other substances Or < / RTI >

Description

[0001] SYSTEMS AND METHODS FOR DIAGNOSTIC TESTING [0002]

Priority claim

This application is related to US Serial No. 61 / 881,901, filed September 24, 2013 entitled " Systems and Methods for Diagnostic Testing " Claims under §119 (e).

Technical field

The present invention relates to a method and system for diagnostic testing involving a computing device. More particularly, the present invention relates to a method and system for performing analytical testing with a diagnostic system configured to communicate with a portable multifunction device (PMD) or other computing device.

1 is a simplified schematic representation of a system for diagnostic testing;
Figures 2 and 3 are simplified perspective views of a system for diagnostic testing;
Figures 4-6 and Figures 7A-7C are simplified perspective views of a sample carrier;
Figures 8A, 8B, 9A, 9B, 10A and 10B are simplified representations of electrochemical detection; And
11-13 are simplified representations of the electrical system of the diagnostic system.

Advances in diagnostics, smart phones and wireless communications have converged into new ways of making medical diagnosis. Just one example of the role of smartphones and diagnostic technologies deployed in our lives in the future is a number of medical applications that are created to serve growing smartphone user populations. Of the nearly one million medical apps (software applications) available today, more than 80% seems to be designed for exercise and biometrics. Most apps are static and reference applications that can not freely accept, interpret, or provide personalized information about users. In addition, most patients diagnosed for a particular medical problem have no immediate access to the tailored treatment program or to the support system surrounding the treatment. Quality healthcare in the form of powerful, simple, and acceptable tools on handhelds or other portable computing devices can provide an enhanced connection between individuals utilizing the potential of the Internet and digital technology.

The present invention relates to devices, systems and methods for performing diagnostic tests. The disclosed diagnostic system can perform analytical tests and communicate with a portable multifunction device (PMD) or other computing device. For example, in some embodiments, the coupling and / or connection between the analyzer and the PMD allows a user (e.g., a healthcare provider) to access and use various rapid, user-friendly, and portable test platforms. A wide range of settings and / or test parameters may be employed, and the need for idiomatic analysis and diagnostic hardware and / or equipment may be minimized or denied, leading to reduced medical costs and increased portability and accessibility of diagnostic tests.

The use of analyzers and individual sample cartridges as disclosed herein provides various advantages in diagnostic tests. For example, the analyzer may comprise an electrical component and be configured to transmit an electrical signal between the PMD and the sample cartridge. Through the analyzer, the PMD can initiate a diagnostic test sequence in the sample cartridge. The analyzer can also send the results of the diagnostic test back to the PMD from the sample cartridge.

1 is a simplified schematic representation of a system 100 for diagnostic testing. As shown in FIG. 1, the system 100 may include a computing device, such as the PMD 101, and an analyzer 130. At the user ' s discretion, one or more sample cartridges 150 may be coupled to the analyzer 130, and a range of diagnostic tests may be performed. For example, the analyzer 130 may be configured to transmit electrical signals between the PMD 101 and the sample cartridge 150, allowing various analytical applications to be provided. These analytical tests include, but are not limited to, sensing or quantifying biological analytes or other chemicals from the sample input, whether gas, liquid, or otherwise, sensing or quantifying analytes, antibodies or antigens, Or < / RTI > other substances.

The user interface 108 may be included on the PMD 101 to allow the user to control some aspects of the analyzer 130 and / or the sample cartridge 150 and may be included in the sample cartridge 150 via the analyzer 130. [ To the user. ≪ RTI ID = 0.0 > This user interface 108 may also provide the user with information about resources, organizations or people that may be of interest, assistance or support to the user based on and / or based on the diagnostic test results.

The PMD 101 may include, but is not limited to, a "smart" mobile phone (e.g., iPhone, Android phone, etc.), a tablet computer (e.g., iPad ), An Android tablet, etc.), a computer, a portable digital assistant (e.g., a PDA such as a Palm or an iPod touch), or a portable computer (e.g., a laptop) have. In another embodiment, the PMD may be a desktop computing device. In yet another embodiment, the PMD may be customizable and / or a specific computing device.

The PMD 101 may provide a plurality of functions associated with the diagnostic system 100. PMD 101 may control the operation of analyzer 130 and / or sample cartridge 150, such as through automated computing device control, manual control from a user via PMD 101, or a combination of both It can be possible. In some embodiments, the PMD 101 may provide power to the analyzer 130 and / or the sample cartridge 150 to operate the analyzer 130 and / or the sample cartridge 150, Allows movement of a substance or component within the analyzer 130 and / or the sample cartridge 150. For example, in some embodiments, the PMD 101 may be used to: 1) control the fluid pump and valve (s) in the sample cartridge 150 to control the movement of reagents, solutions, suspensions, and / Powering and / or controlling the system; 2) power and / or control circuits and / or electrical systems in the analyzer 130 and / or the sample cartridge 150; 3) powering and / or controlling the mechanism to deliver the same sample as the fluid from the sample carrier; 4) powering and / or controlling the resistor to produce a temperature change (such as during thermal cycling); 5) powering and / or controlling the mixing and / or rehydrating component to produce a measurable signal; 6) supplying electricity for electrochemical detection; 7) power on and / or control the purification of the suspension through the on-device filtration process, and the like. In some embodiments, for example, the electrical current may be supplied to the analyzer 130 and / or the sample cartridge 150 from the PMD 101 via one or more connection points (e.g., an interface). Similarly, function commands and other inputs may be received by the analyzer 130 and / or the sample cartridge 106 via electrical or other connections with the PMD 101.

The PMD 101 may also control the self-power supply analyzer 130 and / or the sample cartridge 150 that derive power from an external source other than the PMD 101. The PMD 101 is configured to allow the user to control aspects of the analyzer 130 and / or the sample cartridge 150, view test results, access information about the resources with respect to these test results, It is possible to house and execute a software interface that can enable user information to be communicated to other data collection sites or to a service provider. The PMD 101 may receive and process electronic signals from the analyzer 130 and / or the sample cartridge 150 associated with the materials in the analyzer 130 and / or the sample cartridge 150, For example, via the user interface 108 to the user.

The PMD 101 includes a processor 102, a memory 103, a display 104, an input device 105 (e.g., a keypad, a microphone, etc.), a network interface 106, a power source 107 , A battery), and a device interface 120 (e.g., a docking port or other communication coupling mechanism). The PMD 101 may further comprise a plurality of modules or other components configured to perform various functions and / or actions for diagnostic tests. The module may be stored in the memory 103, as shown in FIG. In another embodiment, the module may comprise a hardware component.

The modules or components may include, but are not limited to, a user interface 108, one or more test modules 109, an authentication engine 110, a signal reader 111, an array reader 112, a support network module 113, The navigation module 114, the welcome module 115A, the tutorial 115B, the category resource engine 116, the global positioning system (GPS) component 117, the map module 118A, the grappling module 118B, ), And other components.

The user interface 108 may present information on the display 104 and facilitate user input through the input device 105. [

One or more test modules 109 may be embodied as a test engine. The one or more test modules 109 may generate and display instructions (e.g., via the user interface 108 on the display 104) relating to performing the diagnostic tests via a plurality of mechanisms , Or may be triggered by or triggered by another module or component.

The authentication engine 110 can read the unique signature from the analyzer 130 and / or the sample cartridge 150 inserted in the PMD 101 and can generate a form that the user can add input to or can be in a static form Generated and displayed. The authentication engine 110 may also be triggered by or triggered by another module or component.

The signal reader 111 can read, process, or interpret electronic signals at the pins of the device interface 120 (or port) of the PMD 101 that may correspond to diagnostic information. The signal reader 111 may also be triggered or triggered by another module or component.

The array reader 112 may read, process, or interpret data or information contained in an array of data generated by other modules or components. The array reader 112 may also be triggered or triggered by another module or component.

The support network module 113 may include various other modules or components that may enable a user to identify, locate, and / or access data that describes the resources that are contained within the support network module 113 and / Lt; RTI ID = 0.0 > and / or < / RTI > The support network module 113 may also be triggered or triggered by another module or component.

The database 114 may store forms and / or data that may be input by the user or in a static form. The database 114 may also send user input to a third party through reading, processing, interpretation, packaging, and transmission to the array stored in the application or memory 103 or via the Internet. The database 114 may also be triggered or triggered by another module or component.

The welcome module 115A may generate and display a form in which the user may add an input or may be in a static form. Tutorial 115B may also retrieve data and display data, including, but not limited to, text, images, and video that may direct the use (or interaction with) other modules or components. The welcome module 115A and the tutorial 115B may also be triggered or triggered by other modules or components.

The category resource engine 116 may generate and display forms in which the user may add inputs or may be in static form. The category resource engine 116 may also retrieve data and display data including, but not limited to, text, images, and video. The category resource engine 116 may generate and display location-specific information based on other hardware and / or software in the PMD 101 (e.g., GPS component 117). The category resource engine 116 may also be triggered or triggered by another module or component.

The GPS component 117 may enable capture, acquisition and / or generation of location information.

The map module 118A may manage and present the map in association with, for example, displaying location information generated by GPS and / or location information of resources, e.g., as specified in the database . The grappling module 118B may manage and present data, such as, but not limited to, a single patient's test results as a function of time, aggregation of patient data with population norms, or aggregation of data from other locations.

The power controller 119 may be operable to determine and / or provide power from the power source 107 to the analyzer 130.

The analyzer 130 may be configured to couple to the PMD 101. Analyzer 130 may be configured as a multi-purpose or reusable analyzer 130. The analyzer 130 may also be described as a non-consumable item since the components of the analyzer 130 are not consumed by performing diagnostic tests. In some embodiments, analyzer 130 may include a fuel cell, such as a battery, that can provide power to analyzer 130, sample cartridge 150, and / or PMD 101. Analyzer 130 may also include one or more electrical systems that may include electrical circuitry and / or electrical components. The electrical system of the analyzer 130 may be used to transmit or transmit electrical signals between the PMD 101 and the sample cartridge 150.

The sample cartridge 150 can be configured to receive and hold the test sample. For example, the sample cartridge 150 can hold a solution in which the test sample is dissolved or otherwise dispersed. The sample cartridge 150 may include an electrode or other sensor capable of performing a diagnostic test on the test sample. The sample cartridge 150 can also transmit and receive electrical signals to and from the PMD 101 via the analyzer 130.

In some embodiments, the sample cartridge 150 is a consumable. In other words, the sample cartridge 150 can be configured for single use. For example, the test sample may be collected and disposed within the sample cartridge 150. Thereafter, the sample cartridge 150 may be coupled to the analyzer 130 and one or more diagnostic tests may be performed. After completion of the diagnostic test, the sample cartridge 150 can be taken out of the analyzer 130 and discarded. Thereafter, another sample cartridge 150 containing another test sample may be coupled to the analyzer 130 and used in a similar manner.

In some instances, the sample cartridge 150 may be provided by the manufacturer in a large quantity or lot. In some embodiments, each lot may include a control sample cartridge that can be used to calibrate the remainder of the sample cartridge 150 in the lot. In another embodiment, the lot of sample cartridge 150 can be calibrated by calibrating a single sample cartridge 150 in a lot against a known control sample. The remainder of the lot of the sample cartridge 150 may not require individual calibration. In another embodiment, the sample cartridge 150 is described in International Patent Publication No. 2014/008316 A2 entitled "Devices, Systems, " filed January 9, 2014, the contents of which are incorporated herein by reference. , and Methods for Diagnostic Testing ", a control sample and a control electrode disposed inside the sample cartridge 150 may be used.

Figure 2 depicts a perspective view of the diagnostic system 100 of Figure 1. As shown in FIG. 2, the system 100 includes a PMD 101 coupled to an analyzer 130. The PMD 101 may be coupled to the analyzer 130 in a variety of ways. For example, the analyzer 130 may include a first interface 136 configured to mate or otherwise couple with an interface on the PMD 101 or other computing device. For example, the first interface 136 of the analyzer 130 may be configured to mate with a computer bus, an input / output port, a power port, and / or another communication port of the PMD 101. When used herein, the term interface may be used to describe physical, electrical, magnetic, and / or fluid connections. Software-related interfaces are also disclosed herein.

In some embodiments, the first interface 136 may be compatible with input / output ports on a smart phone or other smart mobile device. For example, the first interface 136 may be configured to associate with an Apple Lightning (TM) access interface. In some embodiments, the first interface 136 may be configured to couple with a 30-pin connection interface. In yet another embodiment, the first interface 136 may be configured to interface with a standard or compact Universal Serial Bus (USB) connection interface. In yet another embodiment, the first interface 136 may be an audio type interface such as a TS, TRS or TRRS interface. Other standard or proprietary interfaces may be used. Electrical power, electrical signals (e.g., input / output signals), etc. may pass between analyzer 130 and PMD 101 via interface 136.

The analyzer 130 may include a housing 132, which may be referred to as a body member or a casing structure. The housing 132 may be made of various materials. For example, the housing 132 may comprise a polymeric material (e.g., plastic), a metallic material, a glass material, carbon fibers, and / or combinations thereof. Other materials may also be used.

The housing 132 may be used to hold various components of the analyzer 130. For example, the housing 132 may include an electrical system including one or more electronic circuits and / or circuit boards. The electrical system may function substantially similar to a potentiostat, electronic hardware, which may be used to perform electrochemical experiments. The housing 132 may also include a fuel cell, such as a battery or a rechargeable battery pack.

The housing 132 may include one or more ports 137, 138. In some embodiments, ports 137 and 138 may be used to couple analyzer 130 to a power source (e.g., a power outlet). The power source may be used to provide power to the analyzer 130 and / or other components of the system 100. In some embodiments, the power source may be used to charge a rechargeable battery pack disposed within analyzer 130. The power source may also be used to charge a rechargeable battery pack disposed within the PMD 101 or other computing device.

In some embodiments, ports 137 and 138 may be used as network connection ports. In such an embodiment, ports 137 and 138 may be used to couple analyzer 130 to a network, such as a computer system or medical device, via a cable (e.g., an Ethernet cable). Ports 137 and 138 may also be used for other purposes. In some embodiments, analyzer 130 may include a first port 137 to couple analyzer 130 to a power source and a second port 138 to couple analyzer 130 to a network.

The analyzer housing 132 may also include one or more additional components and / or features as desired. Other components and / or features may also be included, including a stand, a handgrip, a carry handle, a switch (e.g., a power switch), a status indicator (e.g., LED status indicator)

As further shown in FIG. 2, a sample cartridge 150 may also be coupled to the analyzer 130. For example, the analyzer 130 may include a second interface 134 configured to mate or otherwise couple with the interface 156 of the sample cartridge 150. Any full or standard interface (e.g., USB, mini-USB, etc.) may be used. An electrical signal can be transmitted between the analyzer 130 and the sample cartridge 150 via the second interface 134 of the analyzer 130 and the interface 156 of the sample cartridge 150. [

The sample cartridge 150 may include a housing 152 that can be placed on or in the test sample. A variety of sample types can be used including but not limited to blood, serum, urine, feces, semen, saliva, nasal swabs, nasopharyngeal swabs, oral swabs, throat swabs, and other biological and / or chemical samples. In some embodiments, the sample cartridge 150 may include all of the equipment and means (e. G., Pumps, valves, reagents, etc.) for performing electrochemical tests. Further, the sample cartridge 150 may interface with the PMD 101 through the analyzer 130 or directly.

In some embodiments, the sample cartridge 150 includes an electrode configured to sense and / or detect one or more analytes, including proteins, nucleic acid sequences, ions, cells, and / or other biological and / (154) or other sensors.

In some embodiments, the sample cartridge 150 may include embedded software or firmware. The buried software can serve as a signature for a particular sample cartridge 150. [ For example, the buried software of the sample cartridge 150 may provide the PMD 101 or other computing device with identifying information (e.g., lot number, sample type, etc.) for the sample cartridge 150. Embedded software of the sample cartridge 150 may also trigger and / or signal certain events within the analyzer 130 and / or the PMD 101.

3 is a perspective view of a system 200 according to another embodiment. The analyzer 230 may be configured to couple to the PMD 201 and to a plurality of sample cartridges 250. The analyzer 230 is shown configured to be coupled to the three sample cartridges 250a, 250b and 250c through three interfaces 234a, 234b and 234c. Other configurations are possible. For example, the analyzer 230 may be configured to couple to two sample cartridges 250 or to four or more sample cartridges 250. By being configured to couple to multiple sample cartridges 250, a high volume diagnostic test can be performed by a single PMD 201 and analyzer 230 within a short amount of time. In some embodiments, the system 200 can be configured such that multiple diagnostic tests can be run in parallel. For example, the diagnostic test can be performed in parallel on the three sample cartridges 250a, 250b and 250c. A plurality of diagnostic tests may be performed simultaneously or substantially simultaneously (e.g., with a time difference start time). Multiple diagnostic tests may also be performed independently of other tests in progress. Additionally, the three sample cartridges 250a, 250b and 250c may contain test samples from the same or a plurality of patients.

The interfaces 234a, 234b and 234c may be configured to mate or combine with the interfaces 256a, 256b and 256c of the sample cartridges 250a, 250b and 250c. Electrical signals can be transmitted to and from the respective sample cartridges 250a, 250b and 250c via these interfaces 256a, 256b and 256c.

In yet another embodiment, the PMD 101 (FIG. 1) or other computing device may be configured to couple to a plurality of analyzers. Each of the plurality of analyzers may be configured to couple to one or more sample cartridges.

The analyzer 130 may also include a fuel cell 146, such as a rechargeable or replaceable battery pack. In another embodiment, the fuel cell 146 may include one or more standard batteries that may be inserted into the analyzer housing 132. As discussed above, the fuel cell 146 may provide power to the analyzer 130. The fuel cell 146 may also provide power to the PMD 101 and / or the sample cartridge 150. The properties of the fuel cell 146 may vary depending on the desire. For example, the fuel cell 146 may be of various shapes and / or sizes. Voltage, charge capacity and / or other attributes may be different.

In some embodiments, electrode 154 or other sensor may be coupled and / or bound to capture a probe, which may include peptides and / or other chemical entities. The chemical entity may enable indirect and / or direct binding of the peptide to electrode 154. For example, the chemical entity may comprise a thiolated hydrocarbon chain, which may be bound to the N-terminus of the peptide. The C-terminal of the peptide may be modified and bound to a plurality of chemical agents including, but not limited to, a redox agent such as methylene blue. In some embodiments, the peptides may have chemical affinity for one or more entities in the sample solution. When there is no junction between these entities and the peptide, the peptide is highly stretchable and can efficiently achieve electron transfer into and out of the redox reagent. When there is a junction between these entities and a peptide, the peptide can become less elastic and binds these entities, including, but not limited to, physically and chemically disturbed by the bound entity and away from the electrode 154 It may lose the efficiency or capability of electron transfer into and out of the redox reagent through a plurality of mechanisms, including moving to a sufficient distance. In some embodiments, the sample cartridge 150 also includes a solution capable of releasing the peptide from the entity.

In another embodiment, the electrode may comprise a DNA sensor, such as an aptamer. In such an embodiment, the electrical conductivity of DNA and / or other oligonucleotide constructs is dependent on its morphology state. For example, when an analyte from a sample is bound or incorporated, the shape of the DNA sensor can be switched, thereby resulting in a modified conduction path between the two oligonucleotide stems. Electrode 154 or other sensor may be used to monitor electron transfer. This electrochemical detection methodology is described in U.S. Patent No. 7,947,443, entitled " DNA and RNA Conformational Switches as Sensitive Electronic Sensors of Analytes ", issued on May 24, 2011 and U.S. Patent No. 7,943,301, &Quot; DNA Conformational Switches as Sensitive Electronic Sensors of Analytes ", each of which is hereby incorporated by reference in its entirety.

In other embodiments, the detection method may include colorimetry and / or fluorescence measurement (i.e., sample cartridge 150 and / or analyzer may include a colorimeter and / or a fluorescence meter). The colorimeter and / or fluorescence meter may be coupled to the sample cartridge 150 and / or other components in the analyzer and may be used to analyze various sample types.

Figures 4, 5, and 6 depict various sample carriers 1372, 1472, 1572 that may be used in accordance with the present invention. For example, in FIG. 4, the sample carrier 1372 includes an absorbent swab 1389 disposed at the end of a handle, stick, or shaft 1391. In some embodiments, the absorbent swab 1389 can be a swab swab comprising nylon or other absorbent material. The absorbent swab 1389 may be configured to absorb the test sample prior to delivery to the sample cartridge 150 (FIG. 2), and then contact the electrode 154 of the sample cartridge 150. In some embodiments, the buffer solution (e.g., in sample vessel 1370) may be used to elute the test sample from the absorbent swab 1389. In another embodiment, one or more components of the diagnostic device may be configured to squeeze and / or release the test sample from the absorbent swab 1389 and onto or into the sample cartridge 150. [

The sample vessel 1370 may have a tubular member and a lid 1354. The lid 1354 can be configured to close or seal the sample vessel 1370 reversibly or irreversibly. In some embodiments, the lid 1354 may be screwed or twisted onto the sample vessel 1370. In another embodiment, the lid 1354 can be snapped onto the sample vessel 1370 through a snap-fit connection.

In some embodiments, the sample vessel 1370 can be configured for use without a separate sample carrier 1372. For example, the solid sample may be placed and dissolved in the buffer solution in the sample vessel 1370. The sample container 1370 can be introduced into the sample cartridge 150 later and analysis of the test sample can be performed.

FIG. 5 depicts another sample carrier 1472. As shown in FIG. 6, the sample carrier 1472 may include a capillary. As indicated by the reference arrow 1473, the fluid sample can be collected and sucked into the capillary through capillary action. A solid sample can also be collected in the capillary, if desired. In some embodiments, the capillaries may be placed in a sample vessel containing a buffer solution (such as sample vessel 1370 depicted in FIG. 4) prior to delivery to sample cartridge 150. In another embodiment, the capillary can be delivered directly to the sample cartridge 150 for diagnostic testing.

Figure 6 depicts another sample carrier 1572. As shown in FIG. 6, in some embodiments, the sample carrier includes a handle 1591 and an end loop 1582. Loop 1582 can collect a plurality of samples (e.g., fluid and / or solid samples). In some embodiments, loop 1582 may be placed in a sample vessel containing a buffer solution (such as sample vessel 1370 depicted in FIG. 4) prior to delivery to sample cartridge 150. In another embodiment, the sample carrier 1572, including the loop 1582, may be delivered directly to the sample cartridge 150 for diagnostic testing.

Figs. 7a-7c depict another sample carrier 1672. Fig. The sample carrier 1672 may include an absorbent swab 1689 and a handle 1691. The sample carrier 1672 can be inserted into the sample container 1670, which can be a test tube having a lid 1654. The sample vessel 1670 may be at least partially filled with a buffer solution 1690.

7A, the sample container 1670 is depicted in an open configuration in which the lid 1654 is peeled off and the sample container 1670 is open. While the sample vessel 1670 is in the open configuration, the sample carrier 1672 can be inserted, as indicated by the reference arrow 1695. 7B, the sample carrier 1672 is partially disposed in the open sample container 1670 and the buffer solution 1690. Further, a part of the handle 1691 is shown protruding outward from the sample container 1670. In some embodiments, this protruding portion may be detached or broken from the sample carrier 1672 such that the lid 1654 can be used to close or seal the sample container 1670, as shown in Figure 7C . In an alternative embodiment, the handle 1691 is short enough to fit into the sample container 1670 so that it does not need to be broken. In Figure 7C, the sample vessel 1670 is depicted as a closed configuration in which the lid 1654 is used to close or seal the sample vessel 1654. The protruding portion of the handle 1691 breaks off from the sample carrier 1672 and the absorbent cotton swab 1689 is placed in the sample buffer 1670 inner buffer solution 1690 and remains immersed.

Figures 8A and 8B depict illustrative representations of electrochemical detection in accordance with another embodiment of the present invention. Specifically, Figures 8a and 8b depict an electrode 1760 configured to measure the transfer of electrons during a diagnostic test. Referring to both the system 100 shown in FIGS. 1 and 2 and the structural diagrams shown in FIGS. 8A and 8B, the system 100 is shown as having a specific diagnostic species as a result of biochemical components immobilized on electrodes 1760 Lt; / RTI > For example, for the HIV test, the HIV-specific peptide or protein 1792 may be immobilized on the electrode 1760 in the sample cartridge 150. In one embodiment, the HIV-specific peptide or protein (1792) is an HIV-specific peptide or protein (1792) that is expressed from a test sample introduced through a sample carrier into a polypeptide chain having a defined structure (such as alpha helices or beta strands or betasheets) Changes the morphology when binding the antibody. A redox-sensitive moiety 1793 that is in communication with the PMD 101 and exhibits a relatively high electron transfer rate (k _ET ) when attached to the amorphous peptide 1792 is bound to this peptide 1792. Upon binding the antibody, the redox-sensitive moiety 1793 moves away from the electrode and k _ET is dramatically reduced. For example, as shown in Figs. 8A and 8B, the distance D ₂ is larger than the distance D ₁ . As a result of the change in k _ET as detected by PMD 101, this mechanism can be used to quantify antibodies in patient samples.

Figures 9a and 9b depict illustrative representations of electrochemical detection in accordance with another embodiment of the present invention. Figure 9a depicts a sensor system 1828a in a non-fastening state (first configuration state) and Figure 9b depicts a sensor system 1828b in a binding state (second configuration state). 9A and 9B, the first oligonucleotide stems 1821a and 1821b and the second oligonucleotide stems 1822a and 1822b are connected together at the junctions 1826a and 1826b. Stems 1821a, 1821b, 1822a, 1822b may comprise double-helix DNA or other nucleic acid constructs. The sensor systems 1828a, 1828b may also include third oligonucleotide stems 1823a, 1823b. The sensor systems 1828a and 1828b include receptors 1824a and 1824b that can form part of the junctions 1826a and 1826b. Receptors 1824a and 1824b may comprise a nucleic acid aptamer sequence selected to bind to a target analyte.

The first stem 1821a, 1821b may function as an electron donor and the second stem 1822a, 1822b may serve as an electron sink (although the reverse configuration may of course be employed). When the analytes 1825a and 1825b bind to the receptors 1824a and 1824b, a morphological change occurs in the sensor systems 1828a and 1828b and the charges between the first and second stems 1821a, 1821b, 1822a and 1822b Resulting in a detectable change in transmission. The morphological change may be caused by adaptive folding, compaction, structural stabilization, or any other modification of the junction in response to binding of the analyte 1825a, 1825b, causing a change in the charge transfer characteristics of the sensor systems 1828a, 1828b .

As further illustrated in Figures 9A and 9B, the sensor system 1828a, 1828b is configured to controllably cause charge transfer between the first and second stems 1821a, 1821b, 1822a, 1822b in the second configuration state , An anthraquinone (AQ) having an aromatic ligand, or a rhodium (III) complex. Additionally, the sensor systems 1828a and 1828b may be attached to or attached to the electrodes 1860a and 1860b disposed in the sample chamber of the diagnostic device. Such an electrochemical detection methodology is further described in incorporated US Pat. Nos. 7,947,443 and 7,943,301.

Figures 10a and 10b depict another exemplary representation of electrochemical detection. 10A depicts sensor system 1928a in a non-fastening state (first state) and FIG. 10B depicts sensor system 1928b in an engaged state (second state). The first oligonucleotide stems 1921a and 1921b and the second oligonucleotide stems 1922a and 1922b are joined together at the junctions 1926a and 1926b. The sensor systems 1928a and 1928b further include receptors 1924a and 1924b that can form part of the junctions 1926a and 1926b.

The first stem 1921a, 1921b may function as an electron donor and the second stem 1922a, 1922b may function as an electron sink (although the reverse configuration may of course be employed). When the analytes 1925a and 1925b are bound to the receptors 1924a and 1924b, a change in shape occurs in the sensor systems 1928a and 1928b and the charges between the first and second stems 1921a and 1921b, 1922a and 1922b Resulting in a detectable change in transmission. For example, prior to binding of the analytes 1925a, 1925b, the charge transfer between the first and second stems 1921a, 1921b, 1922a, 1922b may be substantially disturbed.

In some embodiments, the sensor systems 1928a, 1928b are configured to controllably drive the charge transfer between the first and second stems 1921a, 1921b, 1922a, 1922b in the second configuration, 1927b. Additionally, the sensor systems 1928a and 1928b may be attached to or attached to the electrodes 1960a and 1960b disposed in the sample chamber of the diagnostic device. Such an electrochemical detection methodology is further described in incorporated US Pat. Nos. 7,947,443 and 7,943,301.

As discussed above, the system includes a signal acquisition module, a signal packaging and recall module, a data transmission module, a PMD or other computing device interface module, a cartridge interface module, an analog to digital and digital to analog converter, a current to voltage converter, , A battery, a battery charging module, a plurality of functional modules including an alternating current to direct current and a direct current to alternating current converter, a black charging module, a waveform generating module, and other functional modules.

The electrical circuit may have a plurality of functions and may be configured to include various other functional modules. In one embodiment, the electrical circuit may have a module for acquiring a signal from another module in the system. In another embodiment, these signals may be recalled or packaged by a module in the system and transmitted to another module. In a further embodiment, the electrical circuit may have a plurality of electronic interfaces capable of combining the functional aspects of the system. The electrical circuit may have the ability to interface with one sample cartridge or simultaneously with a plurality of sample cartridges. The electrical circuit may be capable of AC power input to charge the components of the system. This AC power input can be converted to AC by an AC / DC converter. Likewise, the system may use a DC power input, in some embodiments. This DC power input can be converted to AC by a DC / AC converter. In some embodiments, a DC / DC converter can be included and can modulate the characteristics of the power entering the system. An electrical circuit may also receive power from one or more PMDs or other computing devices, which may be coupled to the electrical circuitry via any of a plurality of standard or proprietary electronic and physical interfaces. In some embodiments, the PMD or other computing device may interface with the analyzer and may initiate and maintain master-slave communication to perform functions for a plurality of electrochemical detection tests.

In one embodiment, the electrical circuit can charge the electrodes through the input signal and then sample the output signal from the electrode system at discrete time intervals. The PMD or other computing device may direct the functional module in the circuit to modulate these input signals to the electrodes. Modulation may include, but is not limited to, variable voltage over time; Modification of the shape of the input signal, including but not limited to waveform manipulation; offset; Amplification; And other modulation. In one embodiment of the circuit, these waveform manipulations can be accomplished by the inclusion of a waveform generation module that is capable of generating a plurality of waveforms that differ in signal characteristics of the signal input over time. Such an operation may make it possible to produce an input signal including, but not limited to, a linearly varying waveform, a sinusoidal waveform, a triangular waveform, a rectangular waveform, and other waveforms.

The electrical circuit can perform a plurality of different analytical measurement methods, including, but not limited to, amperometry and square wave voltametry. The electrical circuit may be instructed by the PMD to adjust a plurality of sampling parameters to enable proper data collection from electrochemical reactions taking place in the reaction chamber. These sampling parameters may be adjusted based on the detection method and may include, but are not limited to, a sampling start time, a sampling interval, a sampling length, a sampling frequency, and other sampling parameters. In some embodiments, the functional module in the electrical circuit may convert the analog output signal from the electrode to a digital signal suitable for transmission to a PMD or other computer device for further processing.

In another embodiment, the electrical circuit is capable of transmitting data associated with the PMD or other computing device, either via a physical electronic path, wirelessly, or via any of a plurality of transmission modules.

The output signal from the electrochemical assay can be converted to voltage or current, or amplified, modified or otherwise modified to extract data that can be further processed to describe information about the electrochemical detection reaction.

In one embodiment, the electrical circuit may comprise a plurality of functional modules and components on one circuit board. In other embodiments, these modules and components can be implemented on a number of circuit boards, including but not limited to, for example, but not limited to, increasing the signal-to-noise ratio, improving the performance of modules and components, Lt; / RTI > As an example configuration, modules and components involved in measurement, signal modulation, data transmission, or other functions requiring precision may be placed on one of the circuit boards while the other circuit provides power to the system , Or other functional modules and components.

The functional module in such an electrical circuit may be included in the analyzer, the sample cartridge, or may be any of a plurality of arrangements between the two.

An exemplary electrical system is shown in Figures 11-13. 11, the electrical system 2200 may be 1) voltage or current, 2) a plurality of waveforms and amplitudes, and 3) a plurality of sources; A working electrode 2203 that can be electromagnetically coupled with the sample 2206 in its entirety; A counter electrode 2204; And a reference electrode 2205; Or an input signal 2202 that can originate from other electrical components needed for the electrochemical detection reaction. The system 2000 may also include one or more amplifiers or signal converters 2207, a microcontroller or microprocessor 2208, cartridge data 2209, or an output signal 2210. Other elements may also be included. These functional components may or may not be shielded, depending on design requirements.

The input signal 2202 may originate from any of a plurality of sources including a waveform generation module, a microprocessor, a voltage or current source, or other sources. In some embodiments, the waveform generation module may be located in an analyzer, in software on a PMD or other computing device, in an external source, or in multiple locations including at other locations. The input signal 2202 may vary over time and may have one of a plurality of waveforms including linear, exponential, sine, triangular, spherical, or other waveforms. Other characteristics of the input signal 2202, including phase, offset frequency, amplitude, and other characteristics, may also vary over time. The input signal 2202 can provide a plurality of functions including charging the working electrode 2203 and other functions. Such an interface may also be an interface point to an external device, circuit or software.

Working electrode 2203 may comprise a material such as gold, platinum, carbon, silver, copper or other materials. Working electrode 2203 can direct electronic signals from the circuit to chemical species in the reaction chamber, include electrochemical reactions of interest, and provide other functions.

The counter electrode 2204 may also be referred to as an auxiliary electrode and may include a material similar to the working electrode 2203. Current or voltage can be exerted across the solution by applying a potential between the working electrode 2203 and the counter electrode 2204 and the output signal from the counter electrode 2204 is transmitted, modulated, stored, and processed , And otherwise can be used for detection.

The reference electrode 2205 may be made of a plurality of materials, and the output signal may act as a contrast reference. In one embodiment, such a reference may remain relatively constant throughout the reaction. In another embodiment, the reference electrode 2205 can be coupled with a feedback loop to modulate the reference value based on the nature and kinetics of the reaction.

The current / voltage converter 2207 may provide a plurality of functions including current to potential conversion, potential to current conversion, and other functions. In some embodiments, this converter 2207 may modulate or otherwise modify the output signal based on the current or voltage from the counter electrode 2204 and the reference electrode 2205. In some embodiments, the modulated signal may be transmitted to an analyzer, PMD or other computing device, or elsewhere. In another embodiment, the converter 2207 may amplify the output signal from the reaction chamber 2206.

Data transfer module 2208 may include one or more components including a microprocessor, microcontroller, and other standard electronic components. The data transfer module 2208 may communicate with the analyzer, PMD or other computing device or other external device and may interface with these or other devices. In one embodiment, data transfer module 2208 may store data 2209 associated with an in-system sample cartridge, analyzer, or other element and may store such information 2209 in an analyzer, PMD, or other computing device or other device You can hand it over. Such data may cause the receiving device to regulate its own input, output and operation.

Data 2209 may be stored on module 2208 and may include information including lot number, date, test type, authentication information or electronic signature, quality control information, material information, and other information.

The output signal and interface 2210 may be an output from the reaction chamber 2206 and may have been modulated into the component or by the converter 2207. Such interface 2210 may serve as a means for transmitting such signals to an analyzer, PMD or other computing device, or other location.

12 is another exemplary embodiment of an electronic system 2302 that may enable electrochemical detection reactions and communication between PMDs or other computing devices. Electronic system 2302 includes an electronic subsystem 2301, a battery charger 2303, a battery module 2304, a power source converter module 2305, a PMD or other computing A device communication module 2306, a data storage module 2307, a data transmission interface 2308, a signal output interface 2309, a signal conversion module 2310, a signal input interface 2311, a waveform generation module 2312, But may include a plurality of elements, including any other functional module or component. These functional components may or may not be shielded.

The electronic subsystem 2301 may be substantially equivalent to the electronic system 2200 of Figure 11 while the electronic subsystem 2301 may be external to the electronic subsystem 2301 to increase the functionality of the subsystem 2301. [ Lt; RTI ID = 0.0 > electronic module < / RTI >

Battery charger 2303 may be configured to directly interact with a power source, such as a DC power source, an AC power source, an external battery, or other external power source. In another embodiment, the battery charger 2303 may be configured to connect to the battery 2304. Battery charger 2303 may be configured to condition or modulate power from one of a plurality of external power sources to charge battery 2304. [ In another embodiment, the battery charger 2303 may interface with a plurality of interfaces to provide power to the battery in the PMD or other computing device. In another embodiment, battery charger 2303 may be substantially equivalent to port 138 of FIG. 2 and may include a plurality of interfaces, including a computing device, a 2- or 3-prong outlet, And may include an internal infrastructure suitable for interfacing. In a further embodiment, the battery charger 2303 may be part of a dock for a PMD or other computing device. In some embodiments, the power conversion component may be incorporated into the battery charger 2303.

The battery 2304 can be any type of battery including alkaline, lithium ion or other batteries. In one embodiment, battery 2304 may not be rechargeable and may require replacement after consumption. In another embodiment, battery 2304 may be rechargeable and may interface with battery charger 2303 to receive a power input. In another embodiment, the battery 2304 may provide power to all processes, modules, and components within the system 2302, or may provide power to some processes, modules, and components. The battery 2304 may interface with the power source converter module 2305. In some embodiments, battery 2304 may interface directly with other modules and components of the system.

Module 2305 may convert the power source from AC to DC or from DC to AC as appropriate. The module 2305 may provide power within a suitable range for optimal operation of components, modules, and processes within the system 2302 and the PMD or other computing device, respectively.

In some embodiments, a standard or proprietary interface may provide a means of data passing and communication between the PMD or other computing device and the PMD communication module 2306. Module 2306 may include a microprocessor or microcontroller to establish a master and slave protocol between the PMD or other computing device and the analyzer. For example, software on a PMD or other computing device may communicate with the analyzer and, moreover, the sample cartridge and module 2306 to direct the activity of the electrochemical assay. In another embodiment, the module 2306 may also pass data to the PMD or other computing device. Module 2306 may interact with a plurality of modules, processes, and components within the PMD or other computing device, analyzer, and sample cartridge, including module 2308 and module 2307. [

The data storage module 2307 may store data from other modules, processes, and components. In one embodiment, module 2307 can receive data from subsystem 2301 and store, package, and deliver these data to other modules in system 2302. [ Data storage module 2307 may receive data directly from subsystem 2301 and may pass data to module 2306 for communication to a PMD or other computing device. In another embodiment, data from the subsystem 2301 can be converted from an analog signal to a digital signal and passed to the module 2307. Module 2307 may then create a package or array containing the data and pass it to module 2306 for further processing. Module 2307 may also provide packets of data to other modules in the system in a plurality of sizes.

The data transmission interface 2308 may be substantially equivalent to the module 2208 described above and illustrated in FIG. 12, and in some embodiments, may communicate with the data 2209.

The output signal interface 2309 may be substantially equivalent to the module 2210 described above and illustrated in FIG. 12, and in some embodiments may include a signal conversion module 2310, a data storage module 2307, Or send data to another module.

The signal conversion module 2310 can import data in an analog format and output a digital signal. In doing so, the module 2310 may be, in some embodiments, stored, packaged, and distributed to the other modules in the system 2302 and to discrete May provide a set of values to the module 2307.

The signal input interface 2311 may be substantially equivalent to the module 2302 and in some embodiments includes a waveform generation module 2312, a power source or battery 2304, a power source converter module 2305, And can receive signals modulated from a plurality of sources or from other sources.

The waveform generating module 2312 may be substantially equivalent to the waveform generating module 2312 described above and illustrated in FIG. Waveform generation module 2312 may also be an interface point to an external device, circuit, or software.

13 is an exemplary illustration of aspects of an electronic system capable of enabling electrochemical detection reactions and communication between PMDs or other computing devices.

Schematic diagram 2401 shows a schematic diagram of a system 2402 that includes leads 2402 from an electrode in a reaction chamber solution, one or more output signal modulation modules 2403, one or more filters 2404, an analog to digital converter (ADC) 2405, A plurality of functional modules including a plurality of other modules and components for performing potentiostatic measurements of a plurality of functional modules.

The lead 2402 from the electrochemical reaction chamber may be connected to at least three electrodes including, but not limited to, the above-described working electrode, counter electrode, and reference electrode.

The output signal modulation module 2403 can perform a series of modulation on the output signal from the lead 2402. [ Such modulation may include amplification, frequency, or phase modulation, or other modulation.

Before being passed into the ADC 2405, the output signal from the lead 2402 may be filtered by a plurality of filter types 2404 to increase the signal-to-noise ratio.

The reference feedback loop 2406, if present, can modulate the value of the reference electrode in the reaction chamber.

Various systems and methods, including software implemented methods, may also be used in accordance with the devices and systems disclosed herein. For example, the incorporated International Patent Publication No. 2014/008316 A2 provides an exemplary method, including a software-implemented method that can be used in accordance with the present invention.

Yes

The software is implemented to have a series of interfaces on the PMD 101. For example, the software includes a splash screen that is displayed while the PMD 101 checks electronic components, system status, and / or network connectivity. If either of these checks returns a negative result, an error may appear. If the check returns an affirmative result, the notification may appear and may be prompted to the operator to enter a credential (e.g., username and password, bar code, QR code, biometric marker, etc.). The PMD 101 then allows the operator to execute the commands on the main menu, (2) to inform the operator of the time remaining before the quality control (QC) execution is required, and (3) (4) allows the operator to specify where the test is conducted, by whom, by whom, by whom, and by the lot number, etc. And / or (5) enable the user to enter the quality-management mode, and / or (5) enable the user to enter the quality-management mode. The quality-management mode includes (1) re-executing the initial system check; (2) execute positive control; (3) execute voice control; And / or (4) an option to view the calibration and QC history. The operator can enter patient information, such as by scanning a bar code or QR code or by entering a unique patient identification code.

In some embodiments, the sample is collected from a patient, such as through a nasal swab. The sample is contacted with an electrode of the analyzer for testing. The software in the analyzer and / or PMD 101 may identify the cartridge based on the microcontroller with a device "signature" or similar mechanism. The analyzer tests the cartridge to determine the properties of the sample (e.g., the concentration of the analyte, the presence or absence of the analyte, etc.).

While the analyzer is testing the cartridge, the PMD 101 may display a timer countdown showing the time remaining until the results are available. In some embodiments, the operator may choose to have the PMD 101 initiate an audible or visible alarm when a result is available.

The PMD 101 can display the test results after the test is completed. Test results may include positive or negative results, concentration, and the like. The software may enable the operator to append a comment with a result and a flag to be included (e.g., a flag indicating that additional attention or review is needed). The results can then be sent to a central laboratory, hospital, other provider and / or patient. The results may be sent via a wireless network, a wired network, and / or a cellular network.

Claims (18)

As a system for diagnostic tests
An analyzer comprising a first interface and a second interface, wherein the first interface is configured to couple to a portable multifunction device and the second interface is configured to couple to a sample cartridge; And
A sample cartridge comprising an electrode configured for electrochemical detection of a biological analyte, the sample cartridge comprising: a sample cartridge configured to receive an electrical signal transmitted from the portable multifunction device via the analyzer to initiate a diagnostic test sequence; . The system of claim 1, wherein the portable multifunction device comprises a mobile telephone. The system of claim 1, wherein the portable multifunction device comprises a tablet computer. The system of claim 1, wherein the portable multifunction device comprises a portable computer. 5. The system according to any one of claims 1 to 4, wherein the sample cartridge is a consumable. 5. A system according to any one of claims 1 to 4, wherein the portable multifunction device comprises an interface for user control of the analyzer. 5. A method according to any one of claims 1 to 4, wherein the sample cartridge is configured to transmit a second electrical signal to the portable multifunction device via the analyzer, and wherein the second electrical signal is generated during the diagnostic test sequence , A system for diagnostic testing. 8. The system of claim 7, wherein the portable multifunction device is configured to receive the second electrical signal. 5. The system according to any one of claims 1 to 4, wherein the sample cartridge comprises at least one unique identification code. 5. The system for diagnostic testing according to any one of claims 1 to 4, wherein the sample cartridge is configured to detect a biological analyte carried by at least one of a swab swab, a capillary, and a loop. 5. A system according to any one of claims 1 to 4, wherein the electrode is configured to contact a test sample during the diagnostic sequence. A method for performing a diagnostic test,
Connecting the analyzer to the portable multifunction device;
Connecting the analyzer to the sample cartridge, the sample cartridge including an electrode configured for electrochemical detection of the biological analyte; And
Instructing the portable multifunction device to initiate a diagnostic test sequence within the analyzer for testing against the biological analyte. 13. The method of claim 12, wherein connecting the analyzer to the portable multifunction device comprises initiating a wireless connection between the analyzer and the portable multifunction device. 13. The method of claim 12, wherein connecting the analyzer to the portable multifunction device comprises placing the portable multifunction device in physical contact with the analyzer. 13. The method of claim 12, further comprising contacting the test sample with an electrode, wherein the electrode is in electrical contact with the analyzer. 13. The method of claim 12, further comprising transmitting test results from the analyzer to the portable multifunction device. 17. The method of claim 16, further comprising transmitting the test results from the portable multifunction device via a computer network. As a system for diagnostic testing,
An analyzer comprising a first interface and a second interface, wherein the first interface is configured to couple to a computing device selected from the group consisting of a desktop computer, a portable computer, a tablet computer and a mobile telephone, The analyzer being configured to couple; And
A sample cartridge comprising at least one electrode configured for electrochemical detection of a biological analyte, the sample cartridge comprising: a sample cartridge configured to receive an electrical signal transmitted from the computing device via the analyzer to initiate a diagnostic test sequence; System for diagnostic testing.

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